At the request of MHRA, Novartis Vaccines and Diagnostics S.r.l. is executing a precautionary recall of the above batches. This is due to the presence, in one of the components, of visible protein aggregates that were identified following additional testing during the course of an investigation. Such protein aggregation can occur in influenza vaccines. The aggregation consists mostly of viral proteins expected in the vaccine, and when observed, aggregation is transient and disappears upon shaking as recommended in product labelling. No visible protein aggregates were detected at the time of product release in any of these UK batches.

Based on the information available, there is no evidence of any new safety concerns or of any impact on efficacy. No adverse reactions which may be associated with this issue have been reported to Novartis in connection with these batches. Those who have had a flu vaccine from these batches should have no cause for concern and there is no need for revaccination.

Reuters reported at 16:09 GMT that Canada and Switzerland have lifted the ban on Novartis flu vaccines on the basis that “white particles found in the vaccines were normal clumps of protein particles and did not indicate a safety issue” Canada, Switzerland lift ban on Novartis flu vaccines ZURICH | Wed Oct 31, 2012 4:09pm GMT.

But CHS notes that the news should be reported so that there is at least the possibility that the conduct of drug companies and drug regulators can be subjected to public and political scrutiny. We cannot be sure they tell the truth – as we know some have not done on previous occasions. They may also be wrong. Are white particles in vaccines safe and normal “clumps of protein”. If the news is not reported there is no prospect of anyone scrutinising what is taking place.

The ban on 500,000 doses of flu vaccines manufactured by Novartis extends so far to Canada, Austria, France, Germany, Italy, Spain and non EU state Switzerland but appears to have gone largely unreported in the mainstream media even though the news was put out on the wire by news bureau Reuters. The first ban appears to have been announced by the Italian Medicines Agency: Ban on the use of influenza vaccines in the Novartis Vaccines and Diagnostics25/10/2012. The official Italian document can be downloaded here Comunicazione AIFA. You can search Google News yourself in your own country to check for any mainstream media reports.

STOP PRESS 17:00 October 31: Reuters reported an hour ago that Canada and Switzerland have lifted the ban on Novartis flu vaccines on the basis that “white particles found in the vaccines were normal clumps of protein particles and did not indicate a safety issue” Canada, Switzerland lift ban on Novartis flu vaccines ZURICH | Wed Oct 31, 2012 4:09pm GMT.

But CHS notes that the news should be reported so that there is at least the possibility that the conduct of drug companies and drug regulators can be subjected to public and political scrutiny. We cannot be sure they tell the truth – as we know some have not done on previous occasions and they may also be wrong – are white particles in vaccines safe and normal “clumps of protein”. If the news is not reported there is no prospect of anyone scrutinising what is taking place.

The day after the European bans on the Novartis products, Health Canada stated the problem is common in vaccines, they have seen it before and claim to have had no reports of health problems. But they also fail to report making any effort of any kind to investigate. If this is “common in vaccines” Austria, France, Germany, Italy, Spain and Switzerland would not have banned the vaccines. It seems Health Canada had previously done nothing about it. This time they have been caught out by the European bans and appear to have banned the vaccines as a precaution: Novartis Suspends Distribution of Seasonal Flu Vaccines Agriflu and Fluad in Canada as a Precaution Health Canada News Release October 26, 2012:

OTTAWA – Health Canada would like to provide further information to Canadians about its assessment of the voluntary suspension of use in Europe of the seasonal flu vaccines Agriflu and Fluad.

…. Agriflu and Fluad are two of the seasonal flu vaccines produced by Novartis that have been pulled from use in several European countries pending further examination of white floating material discovered clumping in the vaccines.

………

Clumping of the kind noted in Europe is common in vaccines. Health Canada has previously seen such particles before in other vaccines and has observed no impact on their safety or effectiveness. The Public Health Agency of Canada monitors for adverse events following immunization. To date it has received no reports of serious or unexpected adverse events related to these vaccines.

As a precautionary step, Health Canada asked Novartis to suspend distribution of the vaccines in Canada until a full review of the situation is completed. Novartis has agreed. The Public Health Agency of Canada is also recommending that health care professionals in possession of these vaccines refrain from using them until the review is complete.

And Health Canada also claimed seemingly falsely that the European ban was voluntary by Novartis, but that is not correct – according to the Italian authorities they issued an official ban. That according to Reuters news reports [see links below] was followed by other EU states:

The Italian Medicines Agency has prohibited the use of influenza vaccines Fluad – AGRIPPAL – INFLUPOZZI subunit is INFLUPOZZI ADJUVANTED of Novartis Vaccines and Diagnostics Srl.

The measure was necessary because the Novartis Vaccines and Diagnostics Srl announced the presence of a phenomenon of protein aggregation observed in the production of influenza vaccines submitting reports qualitative assessment, toxicology and pharmacovigilance that do not provide sufficient information to clarify the exact composition of the aggregates, or the impact of the defect on the quality, stability of the vaccine and, consequently, on the safety and efficacy of the same. We are waiting for the further investigations and analyzes deemed necessary also the outcome of the evaluation of the documentation notes that the company will have to send.”

Associated Press eventually also reported the story 27th October: 6 European countries pull Novartis flu vaccines but also added that Novartis had known of the problem since July but had not reported it until now and only to the Italian medicines agency AIFA. AP also reported that by then Austria, France, Germany, Italy, Spain and Switzerland had limited the use of Fluad or Aggripal, or both, after the company reported the appearance of small particles in the vaccine to Italian authorities.

In the light of the recent problems the British Broadcasting Corporation and criticism the British media are facing over not reporting the activities of the television celebrity Sir Jimmy Savile as the most prolific child pervert and molester over a 40 year period, these kinds of failures seem to be common.

You can search Google News yourself in your own country to check for any mainstream news reports. The result of the first page of a search on Google India appearing below seems to indicate the news is not being reported internationally by mainstream news outlets.

(Adds comment from European Medicines Agency) … the announcement by Swiss and Italian authorities on Wednesday that they were banning some fluvaccines… Agrippal is the only Novartis flu vaccine marketed in France.

How have vaccines been silently killing children and adults without seeming to leave any trace? Many unexplained infant deaths have occurred over decades following vaccination but the vaccines are never blamed by health officials as the cause.

New research into Gardasil and Cervarix HPV vaccines just published in the Journal of Pharmaceutical Regulatory Affairs by researchers at the University of British Columbia, Canada reveals what appears to be evidence of the smoking gun – traces indicating the vaccines have been triggering potentially fatal autoimmune vasculopathies. Below we publish the abstract of the new research with a link for you to download and read the full paper.

Autopsy results of two young women who died from seemingly unknown causes following vaccination with the HPV vaccine Gardasil revealed no anatomical, microbiological nor toxicological findings that might have explained their deaths. The two young women suffered from cerebral vasculitis-type symptoms following vaccination with the HPV vaccine Gardasil. Post-mortem brain tissue specimens from their brains were analysed for various immunoinflammatory markers.

So should you risk your daughter’s life and health by exposing her to the HPV vaccine? The vaccine itself is pointless for 12-13 year old British school girls. The chance of death from cervical cancer before age 20 is ZERO [see Cancer Research UK statistics – Cervical cancer mortality Statistics By age] – download stats as a table]. The evidence of duration of protection is 5 years [assuming the vaccine works as claimed – which is unproven and will not be known for 40 years].

The research shows that many of the symptoms reported to vaccine safety surveillance databases following HPV vaccination are indicative of cerebral vasculitis, but are unrecognized as such (i.e., intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits).

CHS has separately obtained evidence showing that British Health officials in the Medicines and Healthcare products Regulatory Agency [MHRA] published analyses of adverse reactions to GSK’s Cervarix vaccine in such a way that the conditions underlying the reported symptoms of 4700 adverse reactions in 4.2 million British schoolgirls could never be identified. This looks like “cooking the books” to ensure no information would be made public which might suggest the vaccine is dangerous – thereby ensuring the lives and health of British school children was put at risk in this mass experiment on these schoolgirls. British health officials have now from this September abandoned GSK’s Cervarix vaccine in favour of Gardasil claiming the change is all due to tendering competition. That of course cannot be correct because the Department of Health was previously heavily criticised for allowing only a single source to supply a vaccine when that resulted in supply difficulties. So leaving a single source for the HPV vaccine would similarly repeat the previously heavily criticised arrangements.

To diagnose an underlying condition it is fundamental that all the symptoms be considered together. What the MHRA officials did was to split up the symptoms each girl suffered to report the symptoms separately under five categories which bore no relation to the potential underlying conditions suffered by these children. A large number of the reported individual symptoms are symptoms of an encephalopathy – which is a general medical term for a brain disease or injury. But it will never be known from the MHRA’s published analyses because 1) all the symptoms were split up and 2) not a single reported adverse reaction was the subject of clinical investigation despite Cervarix being a new vaccine whose full adverse effects were unknown.

98 in every 100 adverse drug reactions are known to be under-reported and symptoms of some vaccine adverse reactions do not appear for months or years so the real rate of adverse reactions from the mildest to the most severe could well have been as high as 1 in every 10 girls receiving the vaccine.

So can we trust government and health officials with anything including when it comes to keeping our children safe from harms they insist the children are exposed to? No. So nothing new there then. Same old same old crooked government behaviours. Which is the bigger risk to your children? World terrorism or your own government? Yes that’s right – government wins that contest by a massive margin. It is unbelievably rare for any of your children to be at risk from terrorist attack. It is vastly more common for your children to be at risk from all manner of government health and other agencies.

And why does our headline refer to sons? It is being suggested the same vaccines be given to boys also. Breathtakingly health officials are coming for your sons too. It is more bizarre than the plot of a Batman movie.

For previous CHS articles about HPV vaccine and the widespread harms they have been causing please see the following:

Lucija Tomljenovic1* and Christopher A Shaw1,2,3
1Department of Ophthalmology and Visual Sciences, University of British Columbia, Canada
2Program in Experimental Medicine, University of British Columbia, Canada
3Program in Neuroscience, University of British Columbia, Canada

Abstract:

Background: The proper understanding of a true risk from vaccines is crucial for avoiding unnecessary adverse reactions (ADRs). However, to this date no solid tests or criteria have been established to determine whether adverse events are causally linked to vaccinations.

Objectives: This research was carried out to determine whether or not some serious autoimmune and neurological ADRs following HPV vaccination are causal or merely coincidental and to validate a biomarker-based immunohistochemical (IHC) protocol for assessing causality in case of vaccination-suspected serious adverse neurological outcomes.

Methods: Post-mortem brain tissue specimens from two young women who suffered from cerebral vasculitis-type symptoms following vaccination with the HPV vaccine Gardasil were analysed by IHC for various immunoinflammatory markers. Brain sections were also stained for antibodies recognizing HPV-16L1 and HPV-18L1 antigen which are present in Gardasil.

Results: In both cases, the autopsy revealed no anatomical, microbiological nor toxicological findings that might have explained the death of the individuals. In contrast, our IHC analysis showed evidence of an autoimmune vasculitis potentially triggered by the cross-reactive HPV-16L1 antibodies binding to the wall of cerebral blood vessels in all examined brain samples. We also detected the presence of HPV-16L1 particles within the cerebral vasculature with some HPV-16L1 particles adhering to the blood vessel walls. HPV-18L1 antibodies did not bind to cerebral blood vessels nor any other neural tissues. IHC also showed increased T-cell signalling and marked activation of the classical antibody-dependent complement pathway in cerebral vascular tissues from both cases. This pattern of complement activation in the absence of an active brain infection indicates an abnormal triggering of the immune response in which the immune attack is directed towards self-tissue.

Practice implications: Cerebral vasculitis is a serious disease which typically results in fatal outcomes when undiagnosed and left untreated. The fact that many of the symptoms reported to vaccine safety surveillance databases following HPV vaccination are indicative of cerebral vasculitis, but are unrecognized as such (i.e., intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits), is a serious concern in light of the present findings. It thus appears that in some cases vaccination may be the triggering factor of fatal autoimmune/neurological events. Physicians should be aware of this association.

Here CHS presents a news release today from the Journal of Orthomolecular Medicine on the continuing efforts in the USA to deny freedom to obtain health giving and sometimes life-saving vitamins and other healthy foods. It reports a recent study showing that the vitamins and food supplements are so safe the risk of mortality is lower than risks of death from a lightning strike and obviously vastly less risky than pharmaceutical drug reactions. The risk of dying from preventable medical injuries in hospitals is 350,000 times greater [in percentage terms that is a 35 million percent greater risk].

Here is the main graphic summarising. Look in the bottom left corner to see how vastly safer herbal remedies vitamins and food supplements are:

[CLICK ON IMAGE BELOW TO OPEN LARGER IMAGE IN NEW TAB/WINDOW AND TO PRINT IMAGE ON ITS OWN]

You can subscribe to the journal for free email updates [see end for link]. It carries good informative journal papers and news.

The efforts of the drug and food industries to elimimate competition, including lobbying to legislate vitamins and food supplements out of existence, continue in the USA following legislation introduced in the EU. Vitamins and food supplements have been proven safe over decades, sometimes centuries and in the case of clean water since the beginning of life on earth. But EU legislation has led to the bizarre situation that it is illegal to advertise that water can help prevent dehydration. These kinds of developments have been reported by CHS here:

Restrictions on Food Supplements are Based on Misinformation

An alert from Europe to the rest of the world

by Gert Schuitemaker, PhD

Introduction: “It can’t happen here” qualifies for top placement on the all-time list of famous last words. The United States still has, for now, over-the-counter access to nutritional supplements. But no one who reads newspapers, watches televised news, or leafs through a magazine can miss the preponderance of negative reporting on vitamins. As OMNS continues to counter such misinformation (this issue is the 145th), we take a look at the real “risks” of dietary supplements. Readers may wish to keep in mind what Dr. Abram Hoffer famously said: “All attacks on supplement safety are really attacks on supplement efficacy.” If supplements are vilified, they can be made prescription. If they are prescription, costs will go up and access will vanish. – Andrew W. Saul, Editor

(OMNS Oct 16, 2012) A recent study explains that the risk of mortality from taking food supplements is far lower than other risks like smoking, pharmaceutical adverse drug reactions, cancer, and even dying from a lightning strike. [1] This important new information is relevant to recent food regulations in the European Union (EU) that are supposed to make commercially sold food supplements safer. The study shows the belief that food supplements are dangerous is mistaken.

The Codex Alimentarius was established In 1963 by the Food and Agriculture Organization of the United Nations (FAO), the World Health Organization (WHO) and later the World Trade Organization (WTO) as an international standard, with guidelines and codes of practice for the sale of food products, including food supplements.[2] In the natural health community, the Codex is considered a threat to freedom of choice and purchase of food supplements because it stipulates what doses of supplements can be sold and what wording may be used in advertising and packaging.

The Codex has not been adopted by the United States, but within the EU, it was signed into law in 2002 with the adoption of the European Food Supplements Directive. This set of regulations restricts the free choice of consumers when purchasing food supplements. To more fully appreciate this issue, it should be understood that compared to the United States, the EU is highly socialized and regulated. Acceptance of such rigid legislation by policy makers and politicians is easier in Europe than on the other side of the Atlantic. But giant food corporations are lobbying for similar limitations in the USA. Thus, the Codex Alimentarius and the EU legislation are considered a likely template for exporting this type of food regulation to the rest in the world.

This type of food legislation is designed to protect every citizen of the EU from suspected risks, even those imagined to be related to taking food supplements. Thus, if a dietary supplement does not have “scientific evidence that it is not harmful,” it is treated as harmful until proven otherwise. . On first thought, many of us would expect that the government has a moral obligation and an implied mandate to research such risks and impose such precautionary laws. However, this paralyzing “dangerous until proven safe” logic recently drove the EU committee in charge to deny claims that water treats dehydration and prunes treat constipation, because there was not enough scientific evidence to make these claims! [1]

Threat to freedom of health

The implementation of the European Food Supplements Directive is imminent. As of December 14, 2012, health claims made on food supplements must be authorized by the European Food Safety Authority (EFSA), based on a very rigid and restrictive set of rules. Of the 4000 claims submitted so far, only about 220 have been accepted. For example, the regulations forbid the use of terms such as ‘energy’ for coenzyme Q10, ‘antioxidant’ for quercetine, and ‘probioticals’ for probioticals on supplement labels. The reason is that the law considers these terms to be unfounded claims of health benefits.

This EU legislation is in opposition to the wishes of consumers who want to take responsibility for their own health. Citizens worldwide fighting for freedom of choice should take note, because the template for global implementation has been set in motion with nothing to stop its assault on your health freedom. In response to this insidious threat, the Alliance for Natural Health International compiled a chart that quantifies the risk of mortality from various causes within the EU.[1]

[CLICK ON IMAGE BELOW TO OPEN LARGER IMAGE IN NEW TAB/WINDOW AND TO PRINT IMAGE ON ITS OWN]

Figure 1. Risk of death from various causes in the EU. First, note the position of the bubbles in the quadrants. The X-axis (horizontal) indicates the risk of mortality for an individual (per million people) when the individual is exposed to the risk. The Y-axis (vertical) indicates the overall risk of mortality per million EU residents. A.The upper right quadrant shows mortality risks that apply to a relatively large proportion of the population, for example cancer or preventable medical injury, and that are also relatively large for individuals when exposed. B. The bottom right quadrant shows that a relatively small proportion of the total EU-population dies from the risk, for example railway work, but an individual has a relatively large risk of mortality from exposure. C. The bottom left quadrant shows a relatively small risk of mortality for the overall EU-population, and that an individual also has a small risk of mortality from exposure. D. The upper left quadrant shows a theoretical risk which is relatively large for the overall population, but is small for an individual when exposed. In reality this cannot occur because if individual risk of death is small, then overall the risk must also be small. The size of each bubble represents the relative risk for individual exposure. Note: the log scale is used to allow the data to be meaningfully presented on one graph, but this implies that the differences in risk are exponentially greater than shown by the bubble positions. Figure adapted from ANHI [1].

Results of the ANHI risk study

Result 1. Smoking and illicit drug use have equally large bubbles (upper right quadrant). This means an equal and relatively large risk of mortality from smoking and drug use for the individual smoker and individual drug user (about 2,500 per million [1:400]). But the overall risk for drug use is much lower because fewer people use illicit drugs than smoke (risk from illicit drug use: ~10 per 1 million EU inhabitants [1: 100,000]; from smoking: ~1,000 per million [1 : 1,000]).

Result 2. Lightning and use of food supplements (lower left quadrant) both represent an extremely small risk. The risk of mortality from food supplement use by individuals is 1 in 100 million, and for being struck by lightning is 80 in 100 million. So the risk of mortality as a result of a food supplement use is 80 times smaller than from lightning.

Result 3. Comparison of the use of food supplements (lower left quadrant) vs. preventable medical injuries in hospitals (upper right quadrant). The relative size of the bubbles shows that the risk of mortality from food supplements is much lower than the risk of mortality from preventable medical injuries in hospitals. Reading from the X-axis, it is apparent that the risk of mortality to individuals from food supplements is extremely small (1 in 100 million), but the risk of mortality from preventable medical injuries in hospitals is thousands of times greater (5,000 per million or 0.5%). Reading from the Y-axis, it is apparent that the overall risk of mortality in the EU from food supplements is even lower (6 in 1 billion or 1 in 170 million) and from preventable injuries during a stay in the hospital about 700 per million [1 in 1400].

Result 4. – Comparison of risk for individual (represented by bubble size and the location on the X-axis):

Use of food supplements

Compared to preventable medical injuries in hospitals

1:351,220

Compared to smoking

1:173,000

Compared to cancer

1:173,000

Compared to pharmaceutical adverse drug reactions

1:123,125

Compared to lightning

1:26

Use of herbal remedies

Compared to preventable medical injuries in hospitals

1:206,600

Conclusion

Taking your daily food supplement in the EU is one of your safest daily activities. Even getting fatally struck by lightning is a bigger risk. The risk of dying from preventable medical injuries in hospitals is 350,000 times greater. The European authorities meant to impose precautionary legislation to protect the EU citizen against the risks they imagined, but in fact their prejudice favoring large food corporations is shown by the risk chart. Food supplements are very, very safe. The Codex Alimentarius is considered by many as an imminent threat to the freedom to take the food supplements of citizens of the US. Unfortunately, like the food legislation in the EU, it is currently being considered as a template for legislation worldwide [3]. This most definitely includes America.

(Dr. Gert Schuitemaker trained as a pharmacist and then completed his PhD in medicine at University of Maastricht. He is the founder of the Ortho Institute in the Netherlands, which publishes Orthomoleculair magazine for health professionals and Fit mit Voeding (“Fit With Nutrition”) for the public. Dr. Schuitemaker has published several books and more than 300 articles.)

For further information:

The Alliance for Natural Health International is a non-governmental organization promoting natural and sustainable approaches to healthcare. ANHl campaigns across a wide range of healthcare fields, including the use of herbal products and essential nutrients in adequate doses. http://www.anh-europe.org and http://www.anh-usa.org

Andrew W. Saul, Ph.D. (USA), Editor and contact person. Email: omns@orthomolecular.org Readers may write in with their comments and questions for consideration for publication and as topic suggestions. However, OMNS is unable to respond to individual emails.

This is a must-read report for every British parent who has a teenage daughter. Full report in the latest 100-page glossy news-stand issue of What Doctors Don’t Tell You magazine. On sale at Tesco, Sainsbury’s, WH Smith and independent newsagents throughout the UK.

From this month (September), British schoolgirls from the age of 12 upwards are being offered a new vaccine to protect against cervical cancer. Gardasil is replacing Cervarix as the NHS’s vaccine of choice to combat HPV (human papillomavirus), which causes the cancer.

But WDDTY reveals that Gardasil is officially the world’s most dangerous vaccine. And the UK government isn’t telling parents the truth about a vaccine that has been responsible for at least 100 deaths and thousands of life-destroying disabilities in the US, where it has been used for four years.

WDDTY challenges the government to answer:

why the UK has so readily embraced Gardasil when take-up has slumped by a third in the US following thousands of reports of adverse reactions, including death

why our drug regulators are being so lax when America’s Food and Drug Administration (FDA) has enforced stronger warnings on the vaccine’s packaging, and is investigating a new reaction known as ‘immunotoxicity’ where the whole immune system is affected

why the UK has accepted a vaccine that has been rejected by India after an early trial, funded by Microsoft billionaire Bill Gates, led to the deaths of seven young girls and another 120 suffered debilitating side effects

why the UK government is wasting NHS resources and money on a vaccine that may save just 40 lives in the UK. Overall, an HPV vaccine may protect against 137 new cases of the cancer. Despite the publicity, especially following the death of Big Brother star Jade Goody, cervical cancer is a rare disease, and one that doesn’t even feature in the list of the 10 most common cancers.

If you want to subscribe, and so guarantee your copy of the new, 100-page glossy magazine every month, please follow this link: